This milestone further solidifies BiVACOR’s collaboration with the FDA following the TAH’s earlier recognition this year as a Breakthrough Device...
Freenome submitted the final module of the premarket approval application to the FDA for the first version test...
Regulatory milestone supports China’s reproductive health goals by enabling radiation-free, high-accuracy ultrasound imaging to assess fallopian tube patency and uterine abnormalities in women. ...
Regulatory green light marks full commercial launch of LungVision, enhancing early lung cancer detection through AI-driven 3D imaging for more precise bronchoscopic diagnostics....
Synchron Debuts First Thought-Controlled iPad Experience Using Apple’s New BCI Human Interface Device Protocol ...
Hyperfine Achieves Clinical Milestone Ahead of Plan With 100th Patient Enrolled in Neurology Office Study Using the Next-Generation Swoop® System ...
BMI OrganBank is developing novel medical devices with potential to significantly reduce the waitlist for lifesaving organ transplants, beginning with kidneys...
With the formation of Demetra Spine and recent acquisitions in the US and Europe, Demetra accelerates its mission to revolutionise spinal surgery through infection-reducing, single-use technologies designed for minimally invasive, value-based care....
Awarded for its proprietary MoRe® alloy-based 2.9 mm rod, the EUROPA® PCF System offers a low-profile, high-strength solution for cervical and upper thoracic spine surgery—now eligible for Medicare reimbursement under the New Technology Add-on Payment programme. ...
New AI models bring precision and speed to neuro-oncology, enabling fully automated volumetric analysis and seamless integration into radiology, surgery, and radiation oncology workflows—advancing diagnostic confidence and patient care. ...
